510(k) · Cleared
ClearedZeiss Infrared 800 with Flow 800 Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Surgical GmbH · IZI System, X-Ray, Angiographic
Cleared on Mar 3, 2010 as substantially equivalent to K061871 (Leica Microsystems, Inc., 2006) and 8 other predicates after a 13-day review. Its family tree reaches back 6 generations to 1994. 4 later devices descend from it.
- Decided
- Mar 3, 2010
- Review
- 13 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 6 generations to K944261 (1994). 11 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK944261 Retina AngiographHeidelberg Engineering · 1994
- 5 generations backK042961 Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · Recalled
- 4 generations backK060867 Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · Recalled
- 3 generations backK063345 Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 2 generations backK072222 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 1 generation backK073088 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008
- This deviceK100468 Zeiss Infrared 800 with Flow 800 OptionCarl Zeiss Surgical GmbH · 2010
- Descendant · cites it directly · 1 of its ownK202391 DIR 800Aesculap, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK243077 Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · 2025
- Descendant · cites it directly · 0 of its ownK231986 Modus IRSynaptive Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK231075 Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800…Carl Zeiss Meditec, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K202391DIR 800Aesculap, Inc. · 2021 · cites it directly1descendant
- K243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · 2025 · 2 generations on0descendants
- K231986Modus IRSynaptive Medical, Inc. · 2024 · cites it directly0descendants
- K231075Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)Carl Zeiss Meditec, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944261 | Retina Angiograph | Heidelberg Engineering | 1994 | — |
| −5 | K042961 | Spy Intra-Operative Imaging System: SP2000 | Novadaq Technologies, Inc. | 2005 | 1 |
| −4 | K060867 | Spy Intraoperative Imaging System | Novadaq Technologies, Inc. | 2006 | 1 |
| −3 | K063345 | Spy Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −2 | K072222 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −1 | K073088 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2008 | — |
| 0 (this device) | K100468 | Zeiss Infrared 800 with Flow 800 Option | Carl Zeiss Surgical GmbH | 2010 | — |
| +1 | K202391 | DIR 800 | Aesculap, Inc. | 2021 | — |
| +2 | K243077 | Affirm 800 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | 2025 | — |
| +1 | K231986 | Modus IR | Synaptive Medical, Inc. | 2024 | — |
| +1 | K231075 | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) | Carl Zeiss Meditec, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IZI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IZI device
- #1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061871 | Leica Model FL800Summary page 1…FLOW" 800 option PREDICATE DEVICES Company: Leica Microsystems Device: Leica FL800 (K061871, K080612) Company: Novadaq Technologies, Inc. Device: SPY Intra Operative Imagi… | 2006 |
| * | K080612 | Leica FL800Summary page 1…0 option PREDICATE DEVICES Company: Leica Microsystems Device: Leica FL800 (K061871, K080612) Company: Novadaq Technologies, Inc. Device: SPY Intra Operative Imaging System… | 2008 |
| * | K042961 | Spy Intra-Operative Imaging System: SP2000Summary page 1…Company: Novadaq Technologies, Inc. Device: SPY Intra Operative Imaging System: SP2000 (K042961, K060867, K063345, K071037, K072222, K071619, K073088) 5 10(K) PREMARKET NOTIFICATION… | 2005 |
| * | K060867 | Spy Intraoperative Imaging SystemSummary page 1…Novadaq Technologies, Inc. Device: SPY Intra Operative Imaging System: SP2000 (K042961, K060867, K063345, K071037, K072222, K071619, K073088) 5 10(K) PREMARKET NOTIFICATION… | 2006 |
| * | K063345 | Spy Imaging SystemSummary page 1…Novadaq Technologies, Inc. Device: SPY Intra Operative Imaging System: SP2000 (K042961, K060867, K063345, K071037, K072222, K071619, K073088) 5 10(K) PREMARKET NOTIFICATION… | 2007 |
| * | K071037 | Spy Intra-Operative Imaging System, Model SP2000Summary page 1…Novadaq Technologies, Inc. Device: SPY Intra Operative Imaging System: SP2000 (K042961, K060867, K063345, K071037, K072222, K071619, K073088) 5 10(K) PREMARKET NOTIFICATION… | 2007 |
| * | K072222 | Spy Fluorescent Imaging SystemSummary page 1…adaq Technologies, Inc. Device: SPY Intra Operative Imaging System: SP2000 (K042961, K060867, K063345, K071037, K072222, K071619, K073088) 5 10(K) PREMARKET NOTIFICATION I… | 2007 |
| * | K071619 | Spy Fluorescent Imaging SystemSummary page 1…nologies, Inc. Device: SPY Intra Operative Imaging System: SP2000 (K042961, K060867, K063345, K071037, K072222, K071619, K073088) 5 10(K) PREMARKET NOTIFICATION INFRARED 8… | 2007 |
| * | K073088 | Spy Fluorescent Imaging SystemSummary page 1…SPY Intra Operative Imaging System: SP2000 (K042961, K060867, K063345, K071037, K072222, K071619, K073088) 5 10(K) PREMARKET NOTIFICATION INFRARED 800 wrrn FLOW 800 OPTION CARL ZEISS M EDITE… | 2008 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 11 ancestors have a recall of any class.
- Of its descendants, K202391 (Aesculap, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K061871.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · IZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 2025
MAUDE reports naming product code IZI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 28 | 6 | 92 |
| 2008 | 6 | 68 | 52 | 101 |
| 2009 | 2 | — | 18 | 132 |
| 2010 | 2 | — | 11 | 252 |
| 2011 | 4 | 104 | 6 | 377 |
| 2012 | 1 | — | 6 | 77 |
| 2013 | 1 | — | 6 | 58 |
| 2014 | 4 | 111 | 5 | 123 |
| 2015 | 0 | — | 14 | 36 |
| 2016 | 1 | — | 7 | 102 |
| 2017 | 2 | — | 1 | 88 |
| 2018 | 2 | — | 2 | 49 |
| 2019 | 2 | — | 2 | 30 |
| 2020 | 1 | — | 2 | 14 |
| 2021 | 1 | — | 1 | 29 |
| 2022 | 1 | — | 0 | 265 |
| 2023 | 3 | 81 | 0 | 1,204 |
| 2024 | 2 | — | 0 | 1,332 |
| 2025 | 2 | — | 0 | 2,171 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Carl Zeiss Surgical INFRARED 800 with the FLOW 800 option is a surgical microscope accessory used in viewing and visual assessment of intra-operative blood flow in the cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after…
Read the full statement (118 words)
The Carl Zeiss Surgical INFRARED 800 with the FLOW 800 option is a surgical microscope accessory used in viewing and visual assessment of intra-operative blood flow in the cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery. Likewise, INFRARED 800 with the FLOW 800 option used during fluorescence guided surgery aids in the visual assessment of intra-operative blood flow as well as vessel patency in bypass surgical procedures in neurosurgery, plastic and reconstructive procedures and coronary artery bypass graft surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100468 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100468: Zeiss Infrared 800 with Flow 800 Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100468
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026